New Drug Combination Holds Promise

A San Diego drug company, BrainCells Inc., made an announcement in August of 2009 that caught psychiatrists by surprise. A clinical trial conducted by BrainCells showed that depression sufferers found relief when treated with a strange regimen of an anti-anxiety medication combined with a garden-variety dietary supplement. Half a year later, the company is taking giant steps toward turning that discovery into a marketplace hit.

BrainCells tested buspirone, a low-dose generic medication for anxiety, in tandem with melatonin, a common over-the-counter supplement on 142 patients. Researcher Mauricio Fava, a vice chair of psychiatry at Massachusetts General Hospital said that the effect of this double therapy was every bit as effective as standard treatments for depression, such as, say, selective serotonin reuptake inhibitors (SSRI). Since then, BrainCells has been working on getting their product out on the market.

Novel Therapy

This combination therapy has been the talk of the psychiatric community and represents a brand new way of treating depression. The innovative medication is different than anything seen before because it works by stimulating the brain to produce new neurons (neurogenesis). The impact of a novel type of therapy cannot be overestimated since some 20 million U.S. citizens suffer from depression.

Current medications don't work for all and have a tendency to cause unpleasant side effects such as sexual dysfunction and weigh gain. BrainCells combo drug/supplement didn't cause similar side effects so can be seen as a serious option for a huge number of people. CEO for BrainCells, Jim Schoeneck comments, “The depression data we showed has really been the big story over the past few months.”

User-Friendly

But of course, a great deal of groundwork must be done to pave the way for the drug to find its way to your drugstore's shelves. First, the drug needs to undergo more clinical testing, and then it needs to win FDA clearance to market the drug, which has received the code name BCI-952. Also, the first trial had participants taking two different pills, and the company must come up with a one-pill formula to make it truly marketable and user-friendly. According to Schoeneck, BrainCells is working toward creating an oral pill that can be taken once daily, just before bed. The company also needs to make sure it's got things squared away in terms of intellectual property.

BrainCell's chief scientist Carrolee Barlow explained how the company discovered BCI-952. The company researchers knew that buspirone was safe and effective in treating anxiety but had never done much good for depression. The scientists decided to test buspirone in combination with around 70 other supplements or medications that were known to be safe, for instance folic acid, and of course, melatonin. Melatonin was felt to be a good bet, since it is known to have an effect on mood. The supplement is a natural hormone that interacts with the immune and central nervous systems and can help to regulate the sleep-wake cycle.